Job Description

Key Responsibilities Strategic Leadership & Technical Oversight

• Drive the MSTG strategy for injectable manufacturing, aligning with corporate goals and regulatory expectations.
• Lead cross-functional teams in the design, development, and optimization of manufacturing processes.
• Provide technical leadership during product lifecycle stages including development, scale-up, commercialization, and post-launch support.

Technology Transfer & Commercialization

• Oversee complex technology transfer projects across multiple sites or products.
• Ensure readiness of manufacturing sites for new product introductions through robust planning and execution.
• Collaborate with R&D, Regulatory Affairs, and Global Technical Operations to ensure successful commercialization.

Process Validation & Compliance

• Lead the design and execution of process validation strategies including PPQ, cleaning validation, and lifecycle management.
• Ensure compliance with global regulatory standards (USFDA, EU, WHO, PIC/S) and internal quality systems.
• Represent MSTG during regulatory inspections and audits, providing expert technical support.

Operational Excellence & Innovation

• Champion continuous improvement initiatives using QbD, Six Sigma, and Lean methodologies.
• Evaluate and implement advanced technologies (PAT, automation, digital tools) to enhance process robustness and efficiency.
• Monitor industry trends and regulatory changes to proactively adapt manufacturing strategies.

Team Development & Stakeholder Engagement

• Build and mentor a high-performing MSTG team, fostering a culture of technical excellence and accountability.
• Engage with senior leadership, cross-functional teams, and external partners to drive strategic initiatives.
• Develop and deliver technical training programs for manufacturing and quality teams.

Qualifications & Experience

M.Pharm / M.Sc. / B.Tech / M.Tech in Pharmaceutical Sciences, or related discipline.
12–18 years of experience in sterile/injectable manufacturing, with significant exposure to MSTG, technical services, or process development.
Proven track record in leading technology transfers, process validations, and regulatory inspections.

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.